Judge rules pharma has ‘ethical' transparency obligation – reaction
Both sides of a bitterly contested legal battle over a major part of the industry's transparency drive have reacted to the judge's verdict.
A judge ruled that the Health Research Authority is acting within the law in pushing through plans for companies to register clinical trials in active recruitment in the UK.
The verdict in the judicial review, requested by the clinical research firm Richmond Pharmacology, backed the Health Research Authority (HRA) to continue with its requirement for all trials to be registered before the first participant is recruited.
The judge considered this to be an ethical requirement to be met by all in the pharma industry – and found that the HRA had not given the impression that it was a legal obligation, as Richmond Pharmacology had contested.
However the judge who heard the arguments at the Adminstrative Court in Manchester, Mr Justice Jay, did take issue with the wording of a Q&A document on the HRA website. Mr Jay ruled the document could be confusing and contained several misleading statements. He recommended the HRA review this, and possibly pay costs as a result - described as ‘the next battle’ between the HRA and Richmond Pharmacology by an industry insider.
Janet Wisely, chief executive of HRA:
“It is a matter of great regret that there has been a public challenge to research transparency in the UK. We are mindful that the vast majority of our colleagues working within commercial clinical research share our ambitions and commitment to greater research transparency.
"We are grateful that Sense About Science participated in the claim. We are also grateful that the Ethical Medicines Industry Group (EMIG) supported the HRA in the case and made clear that the claimant was not representative of the wider clinical research community.”
Oliver Wright, solicitor at law firm LHS, which acted for Richmond Pharmacology:
“Patients and the general public can now continue to have confidence in the way the sector is regulated. The law is now clear and there can be no confusion for the pharmaceutical sector about what constitutes guidance from the regulator and what constitutes legal obligations. The ruling helps ensure companies can continue to operate in the UK with confidence and on a more level playing field with its international competitors”.
Graham Small, senior partner at LHS:
“Challenging a regulator always needs to be carefully considered and respectfully undertaken and it’s not a step taken lightly by any organisation. It’s now up to the Court to determine what is most practical to implement the guidance and recommendations handed down by Mr Justice Jay in this important case. We are pleased that our clients have been vindicated in their pursuit of justice.
“While the matter has been lengthy for our clients and HRA anticipate the important matters raised in the judgement can be swiftly addressed and the UK can remain a global leader in clinical trials.”
Dr Virginia Acha, ABPI executive director of research, medical and innovation:
“The ABPI has long been an advocate of greater transparency in clinical trial data and we are pleased to finally see the full details of this judgement and the review so that we can add our views. We have been fully engaged on clinical data transparency with members and stakeholders through meetings and technical workshops and we welcome the progress achieved by all parties in reaching a consensus in approach for the disclosure of clinical trial information. We look forward to continuing to work with the Health Research Authority to ensure that the UK is a robust and internationally leading place to undertaken clinical research at all phases of study.”
Síle Lane, director of campaigns at Sense About Science:
“This judgment is a victory for clinical trial transparency. The Judge has clearly and comprehensively set out the legal and ethical requirements for clinical trial registration. The HRA has been given a clear mandate to continue its work raising awareness of researcher’s requirements to register trials and to check researchers’ compliance with those requirements. We hope the HRA will start clamping down on breaches of these requirements soon.
“We’re in a time of legislative change, the new EU clinical trials law is going to be adopted into UK law over the next year, so we need to be alive to the discussions that will go on during that adoption. This case has uncovered the arguments people and organisations like Richmond will be making during those discussions. The Judge has told us today that the AllTrials campaign has a lot of useful expertise on these issues. We know we’ll need to be part of those discussions.”
Dr Ben Goldacre, author of Bad Pharma and co-founder of the AllTrials campaign:
“The judge has stated clearly that people conducting trials have ethical obligations, as well as legal ones, and that research regulators are entitled to hold companies to those ethical standards. It is ridiculous that it has taken 5 months of intense legal argument and has cost probably hundreds of thousands of pounds to get this statement of the current situation.
“It is saddening that Richmond ever took this case. Today the judge did a very good service to every UK company working on clinical trials. They should celebrate and capitalise on this success, by telling the world that trials run in this jurisdiction produce reliable evidence, to the highest standards.”
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